Methods
Comparisons by country/arm
- For binary covariates (seroconversion, shedding, etc), comparisons are pairwise Fisher’s exact tests with FDR adjustment.
- For continuous covariates (titre, inflammatory markers, etc), comparisons are ANOVAs of log-transformed values with post-hoc Tukey tests.
- * p <0.05; ** p <0.005; *** p <0.0005.
Comparisons by ORV outcome
- For binary endpoints (seroconversion/shedding), comparisons are logistic regressions.
- For continuous endpoint (post-vaccination RV-IgA), comparisons are linear regressions of log-transformed RV-IgA concentration.
- See Module 5 for full univariate and multivariate analyses of ORV outcome.
- * p <0.05; ** p <0.005; *** p <0.0005.
Shedding by country/arm
Column
Country
Summary of sample sizes
n neonatal_shedding dose1_shedding dose2_shedding either_shedding
India 307 306 305 306 304
Malawi 119 102 101 83 72
UK 60 58 60 56 56
seroconv any_response
India 305 302
Malawi 103 61
UK 51 48ORV shedding
Neonatal and vaccine shedding
Raw data and p values
Neonatal shedding
proportions positive n percent
1 India 136 306 44.4
2 Malawi 6 102 5.9
3 UK 1 58 1.7 p_values p
1 India vs Malawi 0.0000
2 India vs UK 0.0000
3 Malawi vs UK 0.4235Dose 1 shedding
proportions positive n percent
1 India 82 305 26.9
2 Malawi 56 101 55.4
3 UK 55 60 91.7 p_values p
1 India vs Malawi 0.0000
2 India vs UK 0.0000
3 Malawi vs UK 0.0000Dose 2 shedding
proportions positive n percent
1 India 91 306 29.7
2 Malawi 33 83 39.8
3 UK 35 56 62.5 p_values p
1 India vs Malawi 0.0860
2 India vs UK 0.0000
3 Malawi vs UK 0.0148Shedding after either dose
proportions positive n percent
1 India 151 304 49.7
2 Malawi 50 72 69.4
3 UK 54 56 96.4 p_values p
1 India vs Malawi 0.0025
2 India vs UK 0.0000
3 Malawi vs UK 0.0001Shedding after both doses
proportions positive n percent
1 India 22 304 7.2
2 Malawi 15 72 20.8
3 UK 32 56 57.1 p_values p
1 India vs Malawi 0.0015
2 India vs UK 0.0000
3 Malawi vs UK 0.0001Rota shedding (VP6) by time-point
Raw data and p values
Maternal (MS1)
proportions positive n percent
1 India 2 307 0.7
2 Malawi 1 96 1.0
3 UK 2 58 3.4 p_values p
1 India vs Malawi 0.5590
2 India vs UK 0.3610
3 Malawi vs UK 0.5590Week 1 (BS1)
proportions positive n percent
1 India 136 306 44.4
2 Malawi 6 102 5.9
3 UK 1 58 1.7 p_values p
1 India vs Malawi 0.0000
2 India vs UK 0.0000
3 Malawi vs UK 0.4235Week 4 (BS2)
proportions positive n percent
1 India 0 305 0.0
2 Malawi 3 91 3.3
3 UK 4 57 7.0 p_values p
1 India vs Malawi 0.0177
2 India vs UK 0.0017
3 Malawi vs UK 0.4296Week 6/8 (BS3)
proportions positive n percent
1 India 2 305 0.7
2 Malawi 5 88 5.7
3 UK 10 51 19.6 p_values p
1 India vs Malawi 0.0110
2 India vs UK 0.0000
3 Malawi vs UK 0.0203Week 7/9 (BS4)
proportions positive n percent
1 India 43 307 14.0
2 Malawi 36 80 45.0
3 UK 49 59 83.1 p_values p
1 India vs Malawi 0.0000
2 India vs UK 0.0000
3 Malawi vs UK 0.0000Week 10/12 (BS5)
proportions positive n percent
1 India 8 304 2.6
2 Malawi 9 79 11.4
3 UK 24 54 44.4 p_values p
1 India vs Malawi 0.0026
2 India vs UK 0.0000
3 Malawi vs UK 0.0000Week 11/13 (BS6)
proportions positive n percent
1 India 37 306 12.1
2 Malawi 18 84 21.4
3 UK 29 55 52.7 p_values p
1 India vs Malawi 0.0345
2 India vs UK 0.0000
3 Malawi vs UK 0.0003Number of infants with birth shedding, dose 1 shedding, dose 2 shedding and post-vaccination IgA
India Malawi UK
301 53 50 Minimum NSP2 Ct among ORV shedders
P values (pairwise Wilcoxon tests with FDR correction)
comp p fdr
1 India-Malawi 4.995433e-03 7.493149e-03
2 UK-Malawi 2.664895e-01 2.664895e-01
3 India-UK 4.574514e-06 1.372354e-05Arm
Summary of sample sizes
n neonatal_shedding dose1_shedding dose2_shedding either_shedding
India (IPV) 100 99 99 99 98
India (OPV) 207 207 206 207 206
seroconv any_response
India (IPV) 99 97
India (OPV) 206 205Neonatal and vaccine shedding
Raw data and p values
Neonatal shedding
proportions positive n percent
1 India (IPV) 37 99 37.4
2 India (OPV) 99 207 47.8 p_values p
1 India (IPV) vs India (OPV) 0.1097Dose 1 shedding
proportions positive n percent
1 India (IPV) 43 99 43.4
2 India (OPV) 39 206 18.9 p_values p
1 India (IPV) vs India (OPV) 0.0000Dose 2 shedding
proportions positive n percent
1 India (IPV) 22 99 22.2
2 India (OPV) 69 207 33.3 p_values p
1 India (IPV) vs India (OPV) 0.0609Shedding after either dose
proportions positive n percent
1 India (IPV) 54 98 55.1
2 India (OPV) 97 206 47.1 p_values p
1 India (IPV) vs India (OPV) 0.2201Shedding after both doses
proportions positive n percent
1 India (IPV) 11 98 11.2
2 India (OPV) 11 206 5.3 p_values p
1 India (IPV) vs India (OPV) 0.0947Rota shedding (VP6) by time-point
Raw data and p values
Maternal (MS1)
proportions positive n percent
1 India (IPV) 1 100 1.0
2 India (OPV) 1 207 0.5 p_values p
1 India (IPV) vs India (OPV) 0.5461Week 1 (BS1)
proportions positive n percent
1 India (IPV) 37 99 37.4
2 India (OPV) 99 207 47.8 p_values p
1 India (IPV) vs India (OPV) 0.1097Week 4 (BS2)
Not applicable - no shedding observed in IPV arm or OPV arm in week-4 samples.
Week 6/8 (BS3)
proportions positive n percent
1 India (IPV) 0 100 0
2 India (OPV) 2 205 1 p_values p
1 India (IPV) vs India (OPV) 1.0000Week 7/9 (BS4)
proportions positive n percent
1 India (IPV) 23 100 23.0
2 India (OPV) 20 207 9.7 p_values p
1 India (IPV) vs India (OPV) 0.0026Week 10/12 (BS5)
proportions positive n percent
1 India (IPV) 6 99 6.1
2 India (OPV) 2 205 1.0 p_values p
1 India (IPV) vs India (OPV) 0.0162Week 11/13 (BS6)
proportions positive n percent
1 India (IPV) 6 99 6.1
2 India (OPV) 31 207 15.0 p_values p
1 India (IPV) vs India (OPV) 0.0251Number of infants with birth shedding, dose 1 shedding, dose 2 shedding and post-vaccination IgA
India (IPV) India (OPV)
96 205 Minimum NSP2 Ct among ORV shedders
P values
Pairwise Wilcoxon test comp p
1 OPV-IPV 0.4338797Immunogenicity by country/arm
Column
Country
ORV immunogenicity
Raw data and p values
Seroconversion
proportions positive n percent
1 India 85 305 27.9
2 Malawi 24 103 23.3
3 UK 27 51 52.9 p_values p
1 India vs Malawi 0.4398
2 India vs UK 0.0009
3 Malawi vs UK 0.0009Seropositivity, pre-ORV
proportions positive n percent
1 India 99 305 32.5
2 Malawi 5 103 4.9
3 UK 2 56 3.6 p_values p
1 India vs Malawi 0.0000
2 India vs UK 0.0000
3 Malawi vs UK 1.0000Seropositivity, post-ORV
proportions positive n percent
1 India 154 305 50.5
2 Malawi 26 103 25.2
3 UK 30 54 55.6 p_values p
1 India vs Malawi 0.0000
2 India vs UK 0.5556
3 Malawi vs UK 0.0003Infant RV-IgA pre-vaccination
gmts n mean lwr.ci upr.ci
1 India 305 8 6 9
2 Malawi 103 3 3 4
3 UK 56 3 2 4 p_values p
1 India vs Malawi 0.0000
2 India vs UK 0.0001
3 Malawi vs UK 0.7334Infant RV-IgA post-vaccination
gmts n mean lwr.ci upr.ci
1 India 305 20 16 25
2 Malawi 103 9 6 12
3 UK 54 27 17 45 p_values p
1 India vs Malawi 0.0009
2 India vs UK 0.4886
3 Malawi vs UK 0.0016Seropositivity by neonatal infection status in India
0 1
0 138 31
1 67 68Pre-vaccination exposure by country (either seropositivity or week-1 shedding)
India Malawi UK
0 138 80 52
1 166 10 2Arm
ORV immunogenicity
Raw data and p values
Seroconversion
proportions positive n percent
1 India (IPV) 25 99 25.3
2 India (OPV) 60 206 29.1 p_values p
1 India (IPV) vs India (OPV) 0.4990Seropositivity, pre-ORV
proportions positive n percent
1 India (IPV) 27 99 27.3
2 India (OPV) 72 206 35.0 p_values p
1 India (IPV) vs India (OPV) 0.1937Seropositivity, post-ORV
proportions positive n percent
1 India (IPV) 47 99 47.5
2 India (OPV) 107 206 51.9 p_values p
1 India (IPV) vs India (OPV) 0.5410Infant RV-IgA pre-vaccination
gmts n mean lwr.ci upr.ci
1 India (IPV) 99 6 4 9
2 India (OPV) 206 8 6 11 p_values p
1 India (IPV) vs India (OPV) 0.1503Infant RV-IgA post-vaccination
gmts n mean lwr.ci upr.ci
1 India (IPV) 99 17 11 25
2 India (OPV) 206 21 16 28 p_values p
1 India (IPV) vs India (OPV) 0.3423Any response by country/arm
Column
Country
Any response
Raw data and p values
proportions positive n percent
1 India 181 302 59.9
2 Malawi 43 61 70.5
3 UK 46 48 95.8 p_values p
1 India vs Malawi 0.1487
2 India vs UK 0.0000
3 Malawi vs UK 0.0012Arm
Any response
Raw data and p values
proportions positive n percent
1 India (IPV) 62 97 63.9
2 India (OPV) 119 205 58.0 p_values p
1 India (IPV) vs India (OPV) 0.3792RV-IgA vs cumulative shedding
Column
Number of infants with birth shedding, dose 1 shedding, dose 2 shedding, pre-vaccination IgA and post-vaccination IgA
India Malawi UK
301 53 47 Cumulative effect of birth exposure and vaccination on IgA titre
Exposure defined as week-1 shedding or IgA positivity pre-vaccination. Shedding subgroups with <5 infants excluded.
-- -+ +- ++
India 53 84 99 65
Malawi 16 33 2 2
UK 2 44 0 1
P values
India
$`s1I$shedding_group`
diff lwr upr p adj
-+--- 0.2517953 -0.07304050 0.5766310 1.892829e-01
+---- 0.9803076 0.66513578 1.2954794 1.041944e-12
++--- 1.3756276 1.03291698 1.7183382 9.058310e-13
+---+ 0.7285123 0.45381817 1.0032065 2.530073e-10
++--+ 1.1238323 0.81793338 1.4297312 9.047207e-13
++-+- 0.3953200 0.09970339 0.6909365 3.510221e-03Malawi
$`s1M$shedding_group`
diff lwr upr p adj
-+--- 0.4989606 0.1278144 0.8701068 0.009495288Maternal Abs by country/arm/exposure
Column
Country
Number of Indian infants with MB IgA, MB IgG, CB IgG, BB1 IgG and no pre-vaccination RV exposure
[1] 138Pearson’s correlation coefficient for MB RV-IgA and MB RV-IgG (log transformed)
Pearson's product-moment correlation
data: log(t$MB1_IgA) and log(t$MB1_IgG)
t = 8.254, df = 136, p-value = 1.185e-13
alternative hypothesis: true correlation is not equal to 0
95 percent confidence interval:
0.4544851 0.6792457
sample estimates:
cor
0.5777145 Maternal IgA antibody levels
Raw data and p values
Maternal RV-IgA
gmts n mean lwr.ci upr.ci
1 India 305 134 120 150
2 Malawi 103 340 256 452
3 UK 49 186 123 281 p_values p
1 India vs Malawi 0.0000
2 India vs UK 0.1649
3 Malawi vs UK 0.0089Breastmilk RV-IgA
gmts n mean lwr.ci upr.ci
1 India 301 25 22 29
2 Malawi 78 97 84 112
3 UK 30 100 68 146 p_values p
1 India vs Malawi 0.0000
2 India vs UK 0.0000
3 Malawi vs UK 0.9932Arm
Antibody levels
Raw data and p values
Maternal RV-IgA
gmts n mean lwr.ci upr.ci
1 India (IPV) 99 151 123 186
2 India (OPV) 206 126 110 145 p_values p
1 India (IPV) vs India (OPV) 0.1456Breastmilk RV-IgA
gmts n mean lwr.ci upr.ci
1 India (IPV) 99 26 20 33
2 India (OPV) 202 25 21 30 p_values p
1 India (IPV) vs India (OPV) 0.8516Maternal RV-IgG
gmts n mean lwr.ci upr.ci
1 India (IPV) 99 11150 9185 13536
2 India (OPV) 206 9539 8318 10938 p_values p
1 India (IPV) vs India (OPV) 0.1978Cord-blood RV-IgG
gmts n mean lwr.ci upr.ci
1 India (IPV) 99 15482 12986 18456
2 India (OPV) 206 13190 11436 15212 p_values p
1 India (IPV) vs India (OPV) 0.1869Exposure status
Antibody levels
Raw data and p values
Maternal RV-IgA
gmts n mean lwr.ci upr.ci
1 India (exposed) 166 131 113 152
2 India (unexposed) 138 138 115 165 p_values p
1 India (exposed) vs India (unexposed) 0.6633Breastmilk RV-IgA
gmts n mean lwr.ci upr.ci
1 India (exposed) 163 24 20 28
2 India (unexposed) 137 28 22 34 p_values p
1 India (exposed) vs India (unexposed) 0.2795Maternal RV-IgG
gmts n mean lwr.ci upr.ci
1 India (exposed) 166 9642 8305 11195
2 India (unexposed) 138 10476 8835 12422 p_values p
1 India (exposed) vs India (unexposed) 0.4684Cord-blood RV-IgG
gmts n mean lwr.ci upr.ci
1 India (exposed) 166 13497 11761 15489
2 India (unexposed) 138 14279 11873 17171 p_values p
1 India (exposed) vs India (unexposed) 0.6230Maternal Abs vs ORV outcome
Column
Summary
See Module 5 for full univariate and multivariate analyses.
Correlation networks
India
Correlation between of MB1 IgA and CB IgG
Pearson's product-moment correlation
data: log(s_sub$MB1_IgA) and log(s_sub$CB1_IgG)
t = 7.8633, df = 303, p-value = 6.625e-14
alternative hypothesis: true correlation is not equal to 0
95 percent confidence interval:
0.3138832 0.5008302
sample estimates:
cor
0.4116784 Full correlation network
Number with complete antibody data = 297
India (exposed subset)
Number with complete antibody data = 161
India (unexposed subset)
Number with complete antibody data = 136
Malawi
Full correlation network
Number with complete antibody data = 42
UK
Full correlation network
Number with complete antibody data = 40 (breastmilk IgA data excluded as this reduced the number of complete cases from 40 to 22).
Continuous outcomes
Pearson correlation coefficients: maternal antibodies vs pre-vaccination RV-IgA
Pearson correlation coefficients
India_exposed
MB1 RV-IgA -0.1500
BM1 RV-IgA -0.1191
MB1 RV-IgG -0.4216
CB1 RV-IgG -0.3843
BB1 RV-IgG 0.2170P values
India_exposed
MB1 RV-IgA 0.0537
BM1 RV-IgA 0.1298
MB1 RV-IgG 0.0000
CB1 RV-IgG 0.0000
BB1 RV-IgG 0.0050Pearson correlation coefficients: maternal antibodies vs post-vaccination RV-IgA
Pearson correlation coefficients
India India_exposed India_unexposed Malawi UK
MB1 RV-IgA -0.1298 -0.1816 -0.0930 -0.2884 -0.1168
BM1 RV-IgA -0.1367 -0.1077 -0.1599 -0.2594 0.1924
MB1 RV-IgG -0.2608 -0.3711 -0.1644 NA NA
CB1 RV-IgG -0.2109 -0.3291 -0.1209 NA NA
BB1 RV-IgG 0.1027 0.0136 -0.1134 NA NAP values
India India_exposed India_unexposed Malawi UK
MB1 RV-IgA 0.0234 0.0192 0.2782 0.0031 0.4446
BM1 RV-IgA 0.0176 0.1710 0.0619 0.0218 0.3175
MB1 RV-IgG 0.0000 0.0000 0.0540 NA NA
CB1 RV-IgG 0.0002 0.0000 0.1579 NA NA
BB1 RV-IgG 0.0734 0.8617 0.1856 NA NAEffect modification
Model for final RV-IgA vs MB RV-IgA + country
Call:
lm(formula = log(BB2_IgA) ~ log(MB1_IgA) + country, data = s)
Residuals:
Min 1Q Median 3Q Max
-3.9242 -1.5926 -0.0985 1.4952 5.3765
Coefficients:
Estimate Std. Error t value Pr(>|t|)
(Intercept) 4.32175 0.39380 10.975 < 2e-16 ***
log(MB1_IgA) -0.27278 0.07719 -3.534 0.000452 ***
countryMalawi -0.55130 0.23086 -2.388 0.017352 *
countryUK 0.43999 0.30847 1.426 0.154453
---
Signif. codes: 0 '***' 0.001 '**' 0.01 '*' 0.05 '.' 0.1 ' ' 1
Residual standard error: 1.925 on 449 degrees of freedom
(33 observations deleted due to missingness)
Multiple R-squared: 0.06128, Adjusted R-squared: 0.05501
F-statistic: 9.771 on 3 and 449 DF, p-value: 2.956e-06Model with interaction terms
Call:
lm(formula = log(BB2_IgA) ~ log(MB1_IgA) * factor(country), data = s)
Residuals:
Min 1Q Median 3Q Max
-3.8672 -1.5512 -0.1094 1.4675 5.3505
Coefficients:
Estimate Std. Error t value Pr(>|t|)
(Intercept) 4.25958 0.54646 7.795 4.57e-14 ***
log(MB1_IgA) -0.26009 0.10927 -2.380 0.0177 *
factor(country)Malawi -0.04537 0.96101 -0.047 0.9624
factor(country)UK -0.16984 1.19857 -0.142 0.8874
log(MB1_IgA):factor(country)Malawi -0.08881 0.17107 -0.519 0.6039
log(MB1_IgA):factor(country)UK 0.11579 0.22476 0.515 0.6067
---
Signif. codes: 0 '***' 0.001 '**' 0.01 '*' 0.05 '.' 0.1 ' ' 1
Residual standard error: 1.928 on 447 degrees of freedom
(33 observations deleted due to missingness)
Multiple R-squared: 0.06291, Adjusted R-squared: 0.05243
F-statistic: 6.001 on 5 and 447 DF, p-value: 2.177e-05Comparison of fit
Analysis of Variance Table
Model 1: log(BB2_IgA) ~ log(MB1_IgA) + country
Model 2: log(BB2_IgA) ~ log(MB1_IgA) * factor(country)
Res.Df RSS Df Sum of Sq F Pr(>F)
1 449 1663.8
2 447 1660.9 2 2.8825 0.3879 0.6787India vs Malawi
Analysis of Variance Table
Model 1: log(BB2_IgA) ~ log(MB1_IgA) + factor(country)
Model 2: log(BB2_IgA) ~ log(MB1_IgA) * factor(country)
Res.Df RSS Df Sum of Sq F Pr(>F)
1 405 1517
2 404 1516 1 1.0014 0.2669 0.6057UK vs India/Malawi
Analysis of Variance Table
Model 1: log(BB2_IgA) ~ log(MB1_IgA) + factor(country == "UK")
Model 2: log(BB2_IgA) ~ log(MB1_IgA) * factor(country == "UK")
Res.Df RSS Df Sum of Sq F Pr(>F)
1 450 1684.9
2 449 1681.0 1 3.8696 1.0336 0.3099Exposure status (within in India)
Analysis of Variance Table
Model 1: log(BB2_IgA) ~ log(MB1_IgA) + factor(pre_exposed)
Model 2: log(BB2_IgA) ~ log(MB1_IgA) * factor(pre_exposed)
Res.Df RSS Df Sum of Sq F Pr(>F)
1 301 846.95
2 300 843.40 1 3.5517 1.2633 0.2619No significant evidence that the association between maternal RV-IgA and infant post-vaccination RV-IgA differs by country or between high-income settings (UK) vs LMICs (India/Malawi).
EED biomarkers by country/arm/exposure
Column
Country
EED biomarker levels
Raw data and p values
α1AT (week 6/8)
gmts n mean lwr.ci upr.ci
1 India 301 734 676 796
2 Malawi 83 4376 3136 6105
3 UK 48 282 155 511 p_values p
1 India vs Malawi 0.0000
2 India vs UK 0.0000
3 Malawi vs UK 0.0000MPO (week 6/8)
gmts n mean lwr.ci upr.ci
1 India 301 6463 5446 7672
2 Malawi 83 2966 2454 3585
3 UK 47 3766 2413 5878 p_values p
1 India vs Malawi 0.0000
2 India vs UK 0.0399
3 Malawi vs UK 0.6234α1AG (week 6)
gmts n mean lwr.ci upr.ci
1 India 304 722.8 702.8 743.5
2 Malawi 87 519 454.1 593.3$`t$country`
diff lwr upr p adj
Malawi-India -0.3312002 -0.4191556 -0.2432447 0α1AT (week 10/12)
gmts n mean lwr.ci upr.ci
1 India 298 820 742 906
2 Malawi 63 9222 6642 12803
3 UK 51 508 338 763 p_values p
1 India vs Malawi 0.0000
2 India vs UK 0.0065
3 Malawi vs UK 0.0000MPO (week 10/12)
gmts n mean lwr.ci upr.ci
1 India 298 7327 6193 8669
2 Malawi 63 4135 3098 5518
3 UK 51 3082 1974 4812 p_values p
1 India vs Malawi 0.0124
2 India vs UK 0.0003
3 Malawi vs UK 0.5271Arm
EED biomarker levels
Raw data and p values
α1AT (week 6)
gmts n mean lwr.ci upr.ci
1 India (IPV) 97 759 650 887
2 India (OPV) 202 719 653 793 p_values p
1 India (IPV) vs India (OPV) 0.5486MPO (week 6)
gmts n mean lwr.ci upr.ci
1 India (IPV) 97 5291 3902 7176
2 India (OPV) 202 7041 5712 8678 p_values p
1 India (IPV) vs India (OPV) 0.1264α1AG (week 6)
gmts n mean lwr.ci upr.ci
1 India (IPV) 98 708 673 745
2 India (OPV) 205 730 705 755 p_values p
1 India (IPV) vs India (OPV) 0.3207α1AT (week 10)
gmts n mean lwr.ci upr.ci
1 India (IPV) 96 794 673 937
2 India (OPV) 200 829 731 940 p_values p
1 India (IPV) vs India (OPV) 0.6920MPO (week 10)
gmts n mean lwr.ci upr.ci
1 India (IPV) 96 7072 5320 9403
2 India (OPV) 200 7598 6161 9371 p_values p
1 India (IPV) vs India (OPV) 0.6954Exposure status
EED biomarker levels
Raw data and p values
α1AT (week 6)
gmts n mean lwr.ci upr.ci
1 India (exposed) 163 714 639 797
2 India (unexposed) 136 755 666 856 p_values p
1 India (exposed) vs India (unexposed) 0.5020MPO (week 6)
gmts n mean lwr.ci upr.ci
1 India (exposed) 163 6365 5043 8033
2 India (unexposed) 136 6481 5004 8396 p_values p
1 India (exposed) vs India (unexposed) 0.9177α1AG (week 6)
gmts n mean lwr.ci upr.ci
1 India (exposed) 165 714 687 742
2 India (unexposed) 138 733 703 765 p_values p
1 India (exposed) vs India (unexposed) 0.3524α1AT (week 10)
gmts n mean lwr.ci upr.ci
1 India (exposed) 162 771 667 891
2 India (unexposed) 134 878 766 1006 p_values p
1 India (exposed) vs India (unexposed) 0.2020MPO (week 10/12)
gmts n mean lwr.ci upr.ci
1 India (exposed) 162 6611 5234 8350
2 India (unexposed) 134 8540 6699 10888 p_values p
1 India (exposed) vs India (unexposed) 0.1361EED biomarkers vs ORV outcome
Summary
See Module 5 for full univariate and multivariate analyses.
Continuous outcomes
Pearson correlation coefficients: EED markers vs pre-vaccination RV-IgA
Pearson correlation coefficients
India_exposed
α1AT (week 6) 0.0581
α1AT (week 10) -0.0204
MPO (week 6) 0.1368
MPO (week 10) 0.0387
α1AG (week 6) 0.0306P values
India_exposed
α1AT (week 6) 0.0192
α1AT (week 10) 0.1710
MPO (week 6) 0.0000
MPO (week 10) 0.0000
α1AG (week 6) 0.8617Pearson correlation coefficients: EED vs post-vaccination RV-IgA
Pearson correlation coefficients
India India_exposed India_unexposed Malawi UK
α1AT (week 6/8) -0.0325 0.0597 -0.0996 -0.0601 -0.0815
α1AT (week 10/12) -0.0624 -0.0298 -0.0102 0.0835 0.2202
MPO (week 6/8) -0.0294 0.0343 -0.1183 -0.0318 -0.0388
MPO (week 10/12) -0.1112 -0.0618 -0.1239 0.0242 -0.2363
α1AG (week 6) -0.0818 -0.1074 0.0041 -0.0230 NAP values
India India_exposed India_unexposed Malawi UK
α1AT (week 6/8) 0.5748 0.4489 0.2485 0.6013 0.6036
α1AT (week 10/12) 0.2836 0.7064 0.9069 0.5521 0.1325
MPO (week 6/8) 0.6125 0.6641 0.1702 0.7824 0.8072
MPO (week 10/12) 0.0556 0.4347 0.1538 0.8637 0.1138
α1AG (week 6) 0.1546 0.1699 0.9617 0.8327 NANeonatal exposure vs ORV outcome
Column
Pre-exposure by cohort
India Malawi UK
0 138 80 52
1 166 10 2Pre-exposure defined as detection of week-1 shedding (VP6 Ct <35) or seropositivity pre-vaccination (RV-IgA ≥20 IU/ml)
ORV response by exposure status (with Malawi and UK as comparison groups)
Raw data and p values
Dose 1 shedding
proportions positive n percent p
1 India (exposed) 29 164 17.7 1e-04
2 India (unexposed) 52 138 37.7 NAShedding of either dose
proportions positive n percent p
1 India (exposed) 65 164 39.6 2e-04
2 India (unexposed) 84 137 61.3 NASeroconversion
proportions positive n percent p
1 India (exposed) 51 166 30.7 0.2508
2 India (unexposed) 34 138 24.6 NAPre-ORV RV-IgA
group mean lwr.ci upr.ci p
1 India (unexposed) 1.9 1.7 2.2 0
2 India (exposed) 23.7 18.1 31.1 NAPost-ORV RV-IgA
group mean lwr.ci upr.ci p
1 India (unexposed) 5.9 4.6 7.6 0
2 India (exposed) 55.1 41.8 72.8 NAAny response
proportions positive n percent p
1 India (exposed) 87 164 53.0 0.0096
2 India (unexposed) 93 137 67.9 NA